Core Viewpoint - Investors in REGENXBIO Inc. have the opportunity to lead a securities fraud lawsuit against the company due to alleged misleading statements regarding the efficacy and safety of its product candidate RGX-111 [1] Group 1: Lawsuit Details - The Schall Law Firm is reminding investors of a class action lawsuit against REGENXBIO Inc. for violations of the Securities Exchange Act of 1934 [1] - The class period for the lawsuit is defined as between February 9, 2022, and January 27, 2026 [1] - Investors who suffered losses during this period are encouraged to contact the Schall Law Firm before April 14, 2026 [1] Group 2: Allegations Against the Company - The complaint alleges that REGENXBIO made false and misleading statements about RGX-111 while concealing negative data regarding its efficacy and safety [1] - A significant issue arose when an intraventricular CNS tumor was discovered in a participant treated in the RGX-111 study, which contradicted the company's positive statements [1] - The lawsuit claims that the company's public statements were materially misleading throughout the class period, leading to investor damages when the truth was revealed [1]

Core Viewpoint - A class action lawsuit has been filed against REGENXBIO, Inc. for allegedly misleading investors about the viability of its drug candidate RGX-111, which has faced significant safety concerns and regulatory scrutiny [1]. Group 1: Allegations and Legal Proceedings - The lawsuit claims that REGENXBIO misrepresented the safety and efficacy of RGX-111, a gene therapy for MPS I, despite knowing about serious safety issues, including the potential for CNS neoplasm [1]. - The FDA placed a clinical hold on RGX-111 after a participant developed an intraventricular CNS tumor during the Phase I trial, leading to a significant drop in the company's stock price from $13.41 to $11.01, a decline of 17.8% in one day [1]. - Shareholders are encouraged to participate in the class action, with a deadline for lead plaintiff submissions set for April 14, 2026 [1]. Group 2: Company Background - REGENXBIO, Inc. is a clinical-stage biotechnology company focused on gene therapies that deliver functional genes to cells with genetic defects in the United States [1].

NEW YORK--(BUSINESS WIRE)--Rosen Law Firm, a global investor rights law firm, announces a class action lawsuit on behalf of purchasers of securities of REGENXBIO, Inc. (NASDAQ: RGNX) between February 9, 2022 and January 27, 2026, inclusive (the "Class Period†). REGENXBIO is a clinical-stage biotechnology company. For more information, submit a form, email attorney Phillip Kim, or give us a call at 866-767-3653. The Allegations: Rosen Law Firm is Investigating the Allegations that REGENXBIO, Inc. ...

NEW YORK, Feb. 16, 2026 (GLOBE NEWSWIRE) -- Gainey McKenna & Egleston announces that a securities class action lawsuit has been filed in the United States District Court for the District of Maryland on behalf of all persons or entities who purchased or otherwise acquired REGENXBIO Inc. (“REGENXBIO” or the “Company”) (NASDAQ: RGNX) securities between February 9, 2022 and January 27, 2026, inclusive (the “Class Period”). The Complaint alleges that Defendants provided overwhelmingly positive statements to inve ...

Core Viewpoint - A class action lawsuit has been initiated against REGENXBIO Inc. due to alleged misrepresentations regarding its gene therapy product RGX-111, which has faced regulatory challenges following the discovery of a tumor in a trial participant [1][4]. Group 1: Lawsuit Details - The lawsuit, titled Andre Kuik v. REGENXBIO Inc., was filed in the United States District Court for the District of Maryland [1]. - The class action includes all individuals or entities that purchased REGENXBIO securities between February 9, 2022, and January 27, 2026 [1]. Group 2: Product and Trial Information - REGENXBIO's RGX-111 is a one-time gene therapy aimed at treating severe Mucopolysaccharidosis Type I, also known as Hurler syndrome [4]. - The company had previously made positive assertions regarding RGX-111's trial success based on favorable biomarker and safety data from an ongoing Phase I/II study [4]. Group 3: Stock Price Impact - Following the announcement of a clinical hold by the FDA due to the discovery of an intraventricular CNS tumor in a trial participant, REGENXBIO's stock price dropped from $13.41 to $11.01 per share, marking a decline of 17.8% in one day [5]. Group 4: Legal Representation - Levi & Korsinsky, LLP is representing the investors and has a history of securing significant compensation for shareholders in similar cases [6][7]. - Investors are encouraged to step forward before the April 14, 2026 deadline to be considered for lead plaintiff status [6].

My name is Myriam Hernandez Alvarez. I received the Electronics and Telecommunication Engineering degree from the Escuela Politecnica Nacional, Quito, Ecuador, the M.Sc. degree in computer science from Ohio University, Athens, OH, USA, a graduate degree in Business Management from Universidad Andina Simon Bolivar, Quito, Ecuador, and the Ph.D. degree in computer applications from the University of Alicante, Spain.Disclosure: I collaborate professionally with Edgar Torres H, who is also an author on Seeking ...

Core Viewpoint - The article does not provide any specific insights or analysis related to companies or industries, focusing instead on the author's qualifications and disclosures [1][2][3]. Group 1 - The author holds multiple degrees in Electronics and Telecommunication Engineering, Computer Science, Business Management, and Computer Applications from various institutions [1]. - The author collaborates professionally with another individual, ensuring independent analyses while adhering to guidelines [1]. - There is no indication of any stock or derivative positions held by the author in the companies mentioned, nor plans to initiate such positions in the near future [2].

Core Viewpoint - The FDA has issued a Complete Response Letter (CRL) for RGX-121, raising concerns about study eligibility criteria and surrogate endpoints, which may complicate the path to approval for this gene therapy targeting MPS II [2][4]. Regulatory Developments - The FDA accepted the RGX-121 Biologics License Application (BLA) under the accelerated approval pathway, but the Prescription Drug User Fee Act (PDUFA) goal date has been extended from November 9, 2025, to February 8, 2026 [1]. - The CRL outlines several potential paths forward, including conducting a new study, treating additional patients, and using an untreated control arm, which poses challenges in the ultra-rare disease population [2]. Company Actions - REGENXBIO plans to request a Type A meeting to discuss the CRL and aims to resubmit the BLA with additional evidence from global experts to clarify the neuronopathic patient population [3]. - The BLA for RGX-121 was supported by positive biomarker, functional, and safety data from the CAMPSIITE I/II/III trial, demonstrating good tolerability across all patients [3]. Analyst Insights - Analysts note that the CRL reflects structural reasons for not approving the gene therapy rather than safety issues related to a clinical hold [4]. - The FDA's cautious approach indicates a preference for placebo-controlled data before granting accelerated approvals [4]. Market Performance - REGENXBIO's stock carries a Buy Rating with an average price target of $31.38, despite facing regulatory challenges [5]. - The stock showed strong momentum, outperforming the broader market, although it experienced a decline of 10.99% to $9.17 during premarket trading [5][6]. - Recent analyst ratings include Buy from Chardan Capital with a target of $52.00, and Stifel raised its target to $45.00 [6].

Core Viewpoint - Regenxbio announced that the U.S. Food and Drug Administration has declined to approve its drug for a rare disease [1] Company Summary - Regenxbio's drug was intended for a rare disease but has not received FDA approval [1]

Core Viewpoint - REGENXBIO Inc. is under investigation for potential violations of federal securities laws following the FDA's clinical holds on its RGX-111 and RGX-121 programs, which resulted in a significant decline in the company's share price by 30-35% after the announcement [1]. Regulatory Compliance - SEC disclosure rules mandate that public companies must provide material information for informed investment decisions, with Item 8.01 of Form 8-K allowing disclosure of material events not covered by other items [2]. - Rule 10b-5 under the Securities Exchange Act of 1934 prohibits material misstatements and omissions in securities transactions, covering both false statements and omissions of necessary facts [2]. Company Communication - During the Q3 2025 earnings call, CEO Curran Simpson highlighted positive regulatory interactions, noting that the FDA completed inspections with no observations, which may have created an asymmetric view of the company's regulatory status by not disclosing safety concerns being evaluated [3]. - The Q3 2025 earnings call transcript notably lacked any discussion regarding the RGX-111 program for MPS I, despite it being a significant pipeline asset that later faced the same FDA clinical hold, raising concerns about the completeness of information provided to shareholders [4].